Ceisteanna ar Sonraíodh Uain Dóibh - Priority Questions

HSE Expenditure

Stephen Donnelly

Question:

63. Deputy Stephen S. Donnelly asked the Minister for Health the reason for the overrun in health spending in 2018; if he was informed by the HSE in late 2017 or early 2018 that such an overrun was likely; the steps he took to avoid an overrun; the overrun in each health sector; the amount realised in savings to date in 2018 under the HSE's value improvement programme; the amount by which anticipated revenues have fallen short; and if he will make a statement on the matter. [43914/18]

The question concerns the overrun. We are looking at a very hefty overrun for this year. Worryingly, it has been locked into next year as well. I think €625 million is accounted for based on the overrun for this year, which is money we could and should be spending on Sláintecare, on scaling up the system and so forth. When was the overrun signalled to the Minister? Was it signalled in late 2017 or early 2018? If so, what steps did the Minister take to try to avoid this significant overrun? Will he give us the details of what has caused the overrun for this year?

I thank Deputy Donnelly for the question. A number of areas within the HSE are contributing to the overspend in 2018. These include higher payouts under the State Claims Agency, a shortfall in private patient income, a higher level of spend in the acute and disability services sectors and, for example, the additional costs associated with Storm Emma, which amounted to about €40 million. The overspend in services is driven by the non-achievement of planned savings, higher levels and higher complexity of demand, costs associated with meeting national regulatory standards in the disability sector and the need for additional emergency placements for children and young people with disabilities. Finally and importantly, an amount of €280 million was provided in the 2018 Revised Estimates for appropriations-in-aid receipts from the UK in respect of healthcare provided under EU regulations. These receipts are now estimated at €225 million, leaving a shortfall of €55 million against the provision.

The HSE advises that the savings projected to be achieved by year end under the value improvement programme will be in the region of €80 million. The introduction of a savings programme into the HSE's 2018 national service plan reflects the commitment we must have in the health service to achieve greater value and efficiency across the totality of resources at its disposal. With major increases in public funding for our health services in recent years to a level which compares favourably with spending in other countries, it is important that the scope to develop services through the improved management of existing resources also receives ongoing attention.

In presenting its 2018 national service plan in late 2017, the HSE conveyed its view of what it saw as the significant financial challenge of implementing the plan within the allocated budget for 2018. This was not a secret; it was published on pages 2 and 3 of the national service plan. In response, I confirmed to the HSE that the plan was to be framed having regard to the funding available. The health sector was but one of several priority areas competing for additional funding in 2018 from the fiscal space available to the Government. I pointed out that over €600 million in additional funding was provided for the health sector in the 2018 budget and that the HSE’s allocation had increased by approximately 20% since 2015, or by an average of 6.6% per annum, which is ahead of both the programme for Government and the confidence and supply agreement level of increase. Taking the significant 2018 and prior year allocations into account, it is clear that issues of budgetary performance need to be addressed in certain areas and that the HSE should discharge its accountability in this regard under the performance and accountability framework.

Additional information not given on the floor of the House

As part of the monthly performance cycle, my Department holds the HSE to account for its expenditure and for the delivery of the services set out in the national service plan. Performance in respect of service delivery and finance is monitored monthly and, where services are experiencing significant performance issues, the HSE is required to submit an escalation report. Finally, the Government is committed to a significant programme of legislative and managerial reform to improve performance and accountability in the HSE. This includes the Health Service Executive (Governance) Bill 2018, which is currently before the Oireachtas. This legislation will establish an independent board governance structure for the HSE, and as one of its functions will support the chief executive officer and HSE executive team in developing a more effective performance management and accountability system.

What I hear from the Minister causes concern because the Minister is telling us the HSE told him towards the end of last year that it was not a big enough budget and that there would be an overrun. I will read back on exactly what the Minister has said but my understanding of what he said is he heard what the HSE said and told it to go back and come up with a service plan that was within budget. I assume that is what the Minister did. The Minister got the budget he got, which the Dáil voted on. The HSE came back to the Minister late last year and said it was not enough money for the service plan so the Minister had to do one of two things. He had to either increase the budget or reduce the service plan. Did the Minister instruct the HSE to reduce the service plan to make sure the HSE could deliver on budget? Presumably he did. If he did that, what has happened to lead to a nearly €800 million overrun? Saying things like Storm Emma and unforeseen events is not an acceptable rationale. If one is running a €16 billion or €17 billion healthcare system, storms and flu epidemics happen and one plans for the unforeseen and makes sure there are contingency budgets in place. Did the Minister ask the HSE to reduce its service plan to a level that should have allowed it and the Minister to deliver according to budget?

The HSE did not just tell me, it told us all in the HSE service plan, as it does most years, the challenges and risks that exist in an organisation like the HSE. This is not the first year the HSE has needed a supplementary budget. If one looks back to 2006, we had a long-stay charges repayment scheme of €1 billion. We had shortfalls of €240 million and overrun of demand led schemes in 2007, €345 million in 2008, €595 million in 2010 and €680 million in 2014. I am not saying it is a good thing but we all know we need to reform our health service in order that it can deliver value for money and improve services, which is why we have all signed up to the Sláintecare plan. The law is very clear. The HSE has a legal obligation under the Health Act to present a service plan that it signs up to delivering. It can highlight risks and challenges and it did highlight those risks and challenges. Ultimately when it submits a service plan to the Minister of the day, it is committing to deliver the services contained within the service plan. It is its legal responsibility. We need to improve the oversight and governance structures. That is why I have appointed Sir Ciarán Devane as the new chair designate of the HSE board. That is why I want to put a competency-based board in place as well. The Deputy may talk about Storm Emma or the State Claims Agency costs and say they do not explain it but they explain a fair bit of it. Let us just take the State Claims Agency as an example. We cannot predict the level of claims being paid out every year. It as clear there was an overrun in that area. It is clear Storm Emma cost €40 million. It was also clear, let us be honest, that when it came to our acute hospitals and disability sector there was a significant overspend. When the Deputy asks what I told the HSE to do, I certainly did not tell it to reduce those services because when one is the Minister for Health, one does not have the luxury of telling sick people they are to go home and come back the next year. We have to manage. That is the situation that I and all my predecessors have found themselves in.

If we in the Dáil vote the Minister a certain amount of money - last year it was north of €15 billion - and the HSE comes to the Minister and tells him it cannot deliver the service plan for the amount of money the Minister has got from the Dáil, the Minister has three choices. He can come back to the Dáil and tell us he needs an extra €600 million, €700 million or €800 million, whatever the HSE tells the Minister. The other choice is to go back to the HSE and say he is sorry but this is the amount of money Dáil Éireann has voted him and they will have to figure out how to bring this in on budget. No one is suggesting that sick people are sent away. The Minister knows that is not being suggested. Anyone managing a budget anywhere in the world says what they will deliver and what amount of money they have. The third thing, which is what actually happened, if I understand the Minister, is he did not tell the HSE to adjust the service plan according to the budget therefore its warning that it did not have enough money held and we ended up where we are now with a nearly €800 million overrun. Was anything done throughout the year? Did the Minister instruct the HSE to adjust the service plan or capital expenditure plan or whatever it was to bring it in on budget?

That is not what the HSE said. The HSE did not say it could not deliver the service plan. The HSE produced a service plan. It was launched by the then director general and me. It was discussed at the Oireachtas health committee. I am pretty sure it was debated on the floor of the House. It produced it in the knowledge of the resources it had available to it. It did spell out, in correspondence to me, which has been long since published and on page 2 and 3 of the service plan, the risks and the challenges it saw. If one looks back through all service plans, the risks and challenges are always highlighted. Nobody in the HSE said, nor legally could anyone have said, it was producing a service plan it did not believe it had adequate resources to deliver. It has an obligation to produce a service plan it can deliver within the resources. However, having said that it is also clear that when one looks at the HSE's budgetary performance since its establishment, it has almost always required a supplementary budget. The question for all of us in the House and for me as Minister is how we endeavour to move to a better place in that regard. The governance piece we are putting in place is a part of it but I also think reforming the model of healthcare is a part. The Deputy and I have somewhat of a luxury of looking at the available resources from a health prism. The Deputy's party and the Government sat down in budgetary talks last year and had to decide how much money we could give to health and we had to do our very best within that envelope. I did not see anybody agitating for any more than was given on budget day.

Nursing Staff Recruitment

Louise O'Reilly

Question:

64. Deputy Louise O'Reilly asked the Minister for Health the reason in spite of his commitment to address the recruitment and retention crisis affecting the nursing and midwifery professions, the HSE has stated that there is only one nursing application for every four nursing vacancies; and if he will make a statement on the matter. [43842/18]

My question, like all my questions, is relatively simple. It relates to the recruitment and retention crisis, in light of the fact that nurses and midwives in the Irish Nurses and Midwives Organisation, INMO, have rejected the results of the Public Service Pay Commission, PSPC. It strikes me that nothing concrete is being done to address this that works. I am sure the Minister will list whatever it is that he is doing, but it does not appear to have the desired impact.

As Minister for Health, the recruitment and retention of nurses and midwives has been and is a consistent priority for me. Challenges exist in recruitment and retention of these professions, which is not news to the Deputy, as she knows and shares my view. We operate against a backdrop of a global shortage of nurses and midwives. Despite these challenges, however, the data show that we have managed to increase the number of nurses and midwives employed, which should not be ignored in this debate.

When the number of nurses and midwives employed by the HSE is compared between September 2017 and September 2018, it shows there has been an increase of 1,050 whole-time equivalents, including student nurses. Without student nurses, the increase is 1,039 whole-time equivalents. The Deputy refers to a statement made by the HSE in its annual report for 2017 which in many ways confirms what we already know - that we are operating within a competitive recruitment market when it comes to filling positions involving health professionals, not least nurses and midwives.

The recent pay proposals put forward were a positive step towards making the public health service a more attractive place to work for nurses and midwives. The PSPC recommended an increase of 20% to the specialist qualification and location allowances for nurses. The allowances are also to be extended to maternity services. In addition, the commission recommended the eligibility requirements for a senior staff nurse or midwife be reduced from 20 years to 17 years.

The Government also proposed to address the issue of new entrant pay, not just for nurses but across the public service, which will benefit approximately 10,000 nurses to the value of approximately €3,000 each.

I am sorry the INMO rejected these proposals but I respect the outcome of its ballot. On foot of the public service stability agreement, PSSA, Government is making considerable resources available to increase public service pay, including in respect of nurses. This is on the basis that this agreement is honoured by all the parties involved. I understand the INMO will consider its next steps when its executive meets on 5 November but I would like to see all parties, including my Department, come together during the intervening period to see if there is a way forward. Industrial action is not something which any side wants to see. Patients do not wish to see it, and I know nurses do not wish to see it either. I hope that engagement will take place between nurses and their employer in advance of 5 November.

I have some small knowledge of industrial relations between nurses and the State. If the Minister does not acknowledge and address the issue of pay, he will leave nurses and midwives with no choice. The Minister has said, and we all know, the last thing nurses wish to do is contemplate industrial action, but that involves them being given another option. He described the recent pay proposals from the PSPC as a "positive step". Some 94% of those balloted in the INMO have rejected it and, therefore, it is not viewed by them as a positive step.

Will the Minister acknowledge that pay is a factor? I do not mean allowances or any specific element of pay but rather actual pay, that is, what the Minister or I would call pay, which one might have in one's pocket after payday and not any one specific bit thereof that might apply to one person but not to his or her colleagues. Will he acknowledge that pay is central and will he take any steps to address it?

What the Government will do is respect the PSSA to which we asked public service unions to sign up, which they did, and to which the Irish Congress of Trade Unions, ICTU, signed up. I understand the INMO is a member of ICTU and I understand all parties to the PSSA have signed up and have agreed there would be no cost-increasing claims for improvement in pay for the duration of the agreement. That is what the agreement which was signed up to by the unions says, namely, that there will be no increase in pay above and beyond what is spelled out in the agreement.

This is a new agreement and if we start unpicking it at such an early stage it does not say much for honouring agreements that have just been agreed. We asked the PSPC to do a body of work on an expert basis, to come together, analyse data, hear from all sides, receive submissions and make recommendations. It made recommendations which would have put more money in the pockets of many of our nurses and midwives and, on top of that, it recommended pay rises for new entrants, which is an issue which needs to be addressed. I respect the INMO ballot; it has made its decision in that regard. I would like there to be engagement with it in advance of 5 November to see if a way forward can be found which respects the PSSA.

The Minister missed an important point in the PSSA which was also in other agreements, including the one on which Fianna Fáil reneged. The point is that the parties reserve the right to go back to the table and renegotiate if the circumstances change. When I was "back in my twos", as my dad would say, when circumstances changed we were quickly dragged back to the table in order that there would be negotiations on the subject of pay cuts.

Circumstances have now changed and we face a recruitment and retention crisis. All of our talk about Sláintecare, reform and everything else will come to nothing unless we have the staff to deliver. Nurses and midwives are the single biggest cohort in our health service. Other trade unions aside from the INMO now call for a renegotiation of that agreement, just as Fianna Fáil did when it felt the circumstances were right for another agreement. There is scope, therefore, to renegotiate, and I would like to hear something more positive from the Minister about nurses' and midwives' pay. We passed a resolution here where we all agreed pay had to be central, not for a small group, a section or a single cohort but for all nurses and midwives.

I do not wish to engage in a back and forth about industrial relations matters on the floor of the Dáil because I want there to be serious engagement between my Department and the Department of Public Expenditure and Reform, where appropriate, and the INMO in advance of its executive meeting on 5 November to see if there is a way forward. I must respect an agreement that the vast majority of public servants have signed up to, namely, the PSSA, to which ICTU has signed up, which is only a new agreement but which sees many benefits for people across the public service.

I accept there are recruitment and retention challenges, especially the latter in the case of people working in the health service. There are a number of measures in place to try to assist with this in the PSPC. I had hoped they would be accepted in order that we could have further engagement along the lines the PSPC references already in its reports. The Deputy is right when she says we need more nurses working in our health services. They are key to the delivery of Sláintecare and I hope a resolution can be found. It will require engagement, however, that takes place in the context of respecting the PSSA.

Hospital Consultant Recruitment

James Browne

Question:

65. Deputy James Browne asked the Minister for Health his plans for new measures to address the shortfall in consultant psychiatrist numbers; and if he will make a statement on the matter. [43915/18]

What are the Minister's plans for new measures to address the shortfall in consultant psychiatrist numbers?

I will answer this question on behalf of my colleague, the Minister of State, Deputy Jim Daly. Budget 2019 allocated an additional €55 million for the development of mental health services, and I acknowledge Deputy Browne's commitment to this area also. The additional funding allocated to mental health services since 2012 has provided for the recruitment of more than 1,500 posts in mental health since 2012. In the last year alone, the number of psychiatrists increased by 14.

There are 340 consultant psychiatrists in the mental health services and 83 vacancies. The HSE uses locums, short-term contracts and other arrangements to fill many of these posts to support service delivery. In addition, we have developed our capacity in primary care through the funding of 114 assistant psychologists, a new grade whose positive impact I have seen first hand, 20 psychologists and ten advanced nurse practitioners. This will help to manage the demand and improve access to psychiatry services.

A focus of funding for 2019 will be on early intervention and support services that will assist as many service users as possible in dealing with mental health challenges before they require acute or psychiatric care. The Government remains committed to increasing the consultant workforce and there is a significant need for psychiatrists. It is generally acknowledged, however, that there are difficulties in recruiting and retaining certain grades of staff, particularly specialist child and adolescent mental health services, CAMHS, staff and consultant psychiatrists. This is an issue not just in Ireland but internationally.

The HSE undertakes continuing recruitment of consultant psychiatrists. Campaigns have targeted international events involving prospective candidates. In its report published on 4 September, the PSPC identified difficulties in attracting consultant applications for many posts and acknowledged that the pay rates for new entrants had been highlighted as a factor in this. The Department of Public Expenditure and Reform has published proposals regarding mitigation of the extended salary scales for new entrants across the public service under section 4 of the PSSA. Two separate interventions will take place at the fourth and eighth points of pay scales, involving the bypassing of two scale points. This measure will apply from 1 March 2019 and will be applied to eligible new entrants as they reach the relevant scale points on their current increment date. Those between the fourth and eighth points will also benefit from the first intervention on the date of their next normal increment.

I welcome the opportunity to raise the worrying issue of the shortage of psychiatrists in our health system. The PSPC found there were problems, in particular, with recruitment in psychiatry, where there were 458 established posts but only 364 of them had been filled, which is approximately 79%.

However, this level is based on established posts, not on the number that should be in place under A Vision for Change, and the actual number is probably much lower than that. In June 2018, 25 unqualified non-specialist doctors, who were not on the specialist register, were acting as psychiatric consultants, a practice that the President of the High Court, Mr. Justice Peter Kelly, described as "scandalous", and reported the matter to HIQA, the Attorney General and others. It did not receive the coverage it deserved at the time due to other serious health issues in the news. It is clear that there is a serious shortage of psychiatrists, however, when the College of Psychiatrists of Ireland sought to increase the number of trainee places by 10%. This was refused and an increase of only 5% was granted. The Government says that it cannot recruit psychiatrists but, at the same time, will not train them in sufficient numbers. What will the Minister do about this?

I thank the Deputy for his point acknowledging that recruiting psychiatrists is a challenge but also highlighting the increase in numbers while vacancies remain. Given its analysis, the Public Service Pay Commission proposed that the parties to the public service stability agreement jointly consider what further measures could be taken to address the pay differential between pre-existing and new entrant consultants, which has increased following the settlement of the 2008 consultant contract claim.

The Departments of Public Expenditure and Reform and Health have noted the commission's views and consideration will be given to solutions that are line with public sector pay policy and available budgets.

We will now prepare the HSE service plan for 2019. A significant budget is in place for the delivery of mental health services, which will exceed €1 billion, and an additional €55 million will be available for the development of mental health services. The Minister of State, Deputy Daly, also remains eager to identify other ways of supporting mental health services. An example of this was the assistant psychology posts this year, with 111 of 114 filled successfully nationally. I accept there is much more to do but we will look to see how to further progress it in the context of the HSE service plan.

I appreciate that pay is a significant and important factor, but the conditions under which many consultant psychiatrists must work is also causing particular problems. They were taken out of the hospitals and put in the community, and rightly so, under A Vision for Change, but the buildings are not fit for purpose. I have been in many of them and they are often decrepit or lack proper facilities. The psychiatrists tell me that they are spending a great deal of time in these buildings that are not fit for purpose but also performing roles that are not part of their remit such as finding hospital beds, making phone calls, opening letters and so on. That is a waste of time that they should spend with clients. Will the Minister examine the conditions in which many of our mental health services are provided? They are not fit for the psychiatrists, the psychiatric nurses or other allied health professionals or for the patients who have to attend those facilities.

I agree that more must be done on this and I will pass on the Deputy's observations in the context of drawing up the service plan for 2019 with the HSE. In addition to the psychology posts and the benefits they bring to the service, we are also committed to increasing the number of psychiatric nurse undergraduate places by 130 annually by 2021-22. That will increase from 270 undergraduate posts to 400 a year.

On an improved seven day a week services, which returns to the Deputy's point about the level of service we are providing, the HSE is in the final stages of recruiting the staff required to deliver seven day a week mental health service cover for the areas that do not currently have a service in place. It is also expected to be delivered in early 2019.

I will take the Deputy's points on board as we prepare for the HSE service plan 2019.

Hospital Waiting Lists

Louise O'Reilly

Question:

66. Deputy Louise O'Reilly asked the Minister for Health the number of children on the suspended list for scoliosis surgery; the number who have been treated abroad in 2018; and if he will make a statement on the matter. [43878/18]

The parents of children waiting for scoliosis surgery have described the manner in which the lists are treated as an exercise in manipulation, with people being moved from one list to another, and letters being sent to the parents of sick children expecting unrealistically quick replies. "Manipulation" is their word but I do not disagree with them. Can the Minister provide us with information about the suspended list for scoliosis surgery and how many children have been treated abroad?

I thank the Deputy for highlighting this important issue and continuing to return to it, as we rightly should. The development of a sustainable scoliosis service has been prioritised by my Department and the HSE in 2018. An additional €9 million was provided to the Children’s Hospital Group, CHG, in 2018 to support the development and implementation of a sustainable and safe paediatric orthopaedic service for children and young people.

The increased investment in scoliosis has brought stability to the service and the current capacity for services has expanded. The CHG advises that 446 procedures will be delivered this year, compared to 371 in 2017, and 224 in 2016. This represents a doubling of activity since 2016. I acknowledge that it is not her word, but when the Deputy refers to manipulation, we should be clear that the number of procedures being done each year is increasing and will have doubled since 2016.

Waiting list figures for 12 October show 130 patients waiting, which includes patients who have been asked to come in for a procedure, those who have been given a date for a procedure in the near future - often one needs a date that works for the patient both clinically and logistically - and those who are waiting for a date for a procedure. This represents a significant reduction of 61 or 32% in comparison to the same week last year when the list stood at 191 patients.

The CHG advises that a number of families were offered the opportunity to have their child's surgery abroad this year but did not avail of the offer. I can fully understand why this might be the case. This year, one patient has had surgery abroad having deferred the procedure from 2017.

The CHG advises that as of 12 October there were 42 patients on the suspended list for spinal surgery across the hospital group.

The placement of patients on the suspended list for surgery is a clinical decision and is made by the treating clinician in consultation with other medical professionals, the patient and their family. Patients are placed on the suspended list for clinical reasons such as being clinically unwell and unfit for surgery, requiring further investigations and procedures prior to their scoliosis treatment, or their condition being managed conservatively and not requiring surgical intervention at this time.

Families may also request a suspension for non-clinical reasons, which is also understandable.

I understand that 347 surgeries have been performed to date. The Minister gave the target for this year. To hit that, 100 further surgeries must be performed between now and the end of the year, including the Christmas period. Is the Minister confident that these will take place? To be straight with him, I would not

I refer to the number of surgeries abroad that are offered and not taken. I have spoken to many parents who are involved in this and their advocates. They say that it is not a significant number and the factor which influences this is the availability of follow-up care here. Even where it has been offered, parents cannot avail of it without the follow-up care here which is not always available. What is the precise number? Is he confident that 100 surgeries will be performed, based on the figures to date?

I do not have the figure for how many people have been offered surgery abroad but I will get it for the Deputy quickly. I want to re-emphasise that the CHG advises that clinical criteria for determining a care plan for scoliosis-related surgeries and other spinal procedures is complex, which we appreciate, and is based on established clinical guidelines and best practice, both nationally and internationally. These are decisions being made by good surgeons who are operating in our health service.

I am confident that the hospital Group will meet the target for procedures. They did 224 in 2016. The Deputy may have asked me the same question last year, when they reached 371, and now they will build on that again to reach 446. Not only has there been additional recruitment of consultants but Cappagh hospital is also doing more work. It is envisaged that the hospital will complete 50 paediatric spinal surgeries in 2018, against a target of 39 for this year. That is a good example of increasing capacity for scoliosis surgeries in Ireland, which we need to do. This year the CHG aims to deliver 446 procedures, which represents an increase in activity of 99.5% on 2016. We have a lot more to do but we are making progress.

This is complex but complications can also arise for these children as a result of having to wait. Their condition can deteriorate to the point where surgery may not be viable. This morning, I spoke to a parent who asked what will happen to children who are left with permanent impairment as a result of delays.

Whether we accept the extent to which they are being dealt with effectively, we all acknowledge that there are delays. Will the Minister apologise to those children and consider offering them some form of compensation? Some of them will live with this damage for the rest of their lives. They are still young.

I want to draw attention again to the fact that the theatre in Crumlin hospital is still only open three days a week. If it was open five days a week, that would be a statement of intent that we are serious about sorting out the problem.

Funding has been provided to increase the capacity for additional consultants in order that even more procedures can be carried out in the hospital. The reconfiguration of the existing orthopaedic post in Crumlin hospital is being worked through the consultant appointment approval committee. Funding for an additional two new consultant posts for paediatric orthopaedics has been provided this year. Those posts are currently being processed and we expect that appointments will be made by the end of this year. These posts are allocated to Crumlin and Temple Street hospitals for paediatric orthopaedics in order that existing consultants can focus on spinal surgery services. The Mater Hospital has also been successful in the recruiting consultants ahead of profile.

We are making a lot of progress on this. I accept that children can often be clinically suitable for surgery one week, but because of the complexity of things can find themselves, on the basis of clinical advice, not being able to have surgery a week or two later, which causes significant difficulties and stress for families. For that reason, the scoliosis co-design team is working with three advocacy groups, the consultants and Mr. Brian O'Mahony as the independent chair, to come up with a pathway of care. It is the appropriate thing to do. I am confident that much good progress has been made in this area, but I am also confident that the solution will involve a sustainable service that will mean we do not have to rely on outsourcing. We should not just seek to fix the problem this year but ensure we are able to look after our children in this country. We are seeing a lot of progress in this area.

Medicinal Products Reimbursement

Alan Kelly

Question:

67. Deputy Alan Kelly asked the Minister for Health when the agreement with a company (details supplied) will be completed regarding the treatment of 19 alpha 1 clinical trial patients; his plans to extend the treatment to all other alpha 1 patients; the timeline for same; and if he will make a statement on the matter. [43846/18]

As the Minister will be aware, my neighbour, Ms Marion Kelly, passed away on 1 December last year. She was one of the 21 Alpha-1 patients on the clinical trial for Respreeza. In August 2017, the HSE said that it would not provide reimbursements for this drug. There was then a stand-off for a number of months when two patients, including Marion, passed away having been off the drug for six weeks. There have been many discussions and a number of meetings. The Minister has met the family on two occasions at my request, to be fair to him. However, everything is at a stand-still. What is the status of the negotiations with the drug company regarding this important trial? The 19 patients still on the trial, and others who need the drug, need to know.

I thank the Deputy not just for raising this matter but for his advocacy in this area and for introducing me to the family of Marion Kelly. I have seen first hand, through his work, their dedication to making sure that this issue is resolved for the 19 families. I share that determination. The HSE assessed the application for the pricing and reimbursement of Respreeza and in August 2017, the manufacturer, CSL Behring, was notified that the HSE did not recommend reimbursement.

A number of patients were on an access scheme for this product, operated by the manufacturer. That scheme was being run independently by the manufacturer without reference to the HSE. The company notified the HSE that it had decided to terminate the access scheme from 30 September 2017. The Deputy knows my views on this; I believe it was a very unethical and inappropriate thing to do. Clinical trials involve a duty of care for people, but we have been over that ground previously.

Following interventions by the HSE, the company modified its decision and agreed to continue to supply the medication free of charge for the patients on the access scheme. Due to the critical and exceptional circumstances, the HSE agreed to fund the provision of the necessary nursing service, which does not usually happen, to ensure patients could continue to receive the medicine

The HSE is continuing to liaise with the treating consultant and the company and has now drafted the terms of an agreement for the long-term care of the 19 Alpha-1 clinical trial patients. This proposal is being reviewed by the company and I am informed that a final agreement should be reached shortly. I view this group of 19 patients as separate and distinct. We have a duty of care to these patients because they were on this medication for so long.

On the broader issue of the provision of Respreeza to other patients, it is open to the company to submit a new reimbursement application to be assessed. As the Deputy will appreciate, I have no statutory role in that regard. I understand that a new application has not been submitted.

There are two distinct issues. The first concerns how we look after and care for the 19 patients involved in the trial. I am happy that good progress has been made there. I am informed that a final agreement should be reached shortly and the terms of that agreement have now been drafted, and I am happy to keep in direct contact with the Deputy on that. The second relates to the broader cohort of patients. The company can submit another application on that if it wishes.

I appreciate the honesty with which the Minister has addressed the question. Unfortunately, we have been at this juncture for a long time, and it is frustrating. The Minister met the family in April. We had a commitment from the HSE that there was going to be an agreement on the 19 patients quickly. Meetings were supposed to take place quickly but they did not happen. A meeting took place in June, and there was a follow-up meeting to that. There is frustration that this process has been going on for a year, and we have had no guarantee that these 19 patients will continue on the drug and that it will be administered in the correct way. We need the guarantee. We cannot allow these 19 patients, and those who need this drug, to continue to live in limbo. It is not acceptable. To be frank, the family of Marion Kelly are exhausted; phone calls and emails are not being answered anymore

I accept that this has been going on for a long time, and I would be interested to hear directly from the Deputy about the failure to respond to emails so that I can pursue that matter. He has separated the two issues. The broader reimbursement issue for patients beyond the 19 on the trial is a matter of, in the first instance, the company submitting an application. I am open to correction, but the information available to me from the HSE is that that has not yet happened. If such an application is received, it will be assessed in accordance with the laws passed in these Houses. The case of those 19 patients on the trial is a distinct issue. I am in full agreement with the Deputy in that regard. I do not believe that people can be on a clinical trial for such a long time with the company then deciding one day to no longer provide the drug. Those people are left in an unenviable and difficult position. I am pleased that progress is being made and that the draft terms of agreement are now in place and with the company for review. As a result of this question, I will check with the HSE on the timeline for the conclusion of the terms of agreement.

I do not want to be here in a month asking the same question on the anniversary of Marion Kelly's passing. She died on 1 December, and she was in my office not long before she passed away. This is important for those who are fighting on behalf of the remaining 19 patients. I also acknowledge the work of Deputy Brassil on this matter. He tabled a parliamentary question to which the Minister gave a disappointing response, which is why I am speaking about this matter today. I have also discussed the matter with the Kelly family, which has contacted me on a regular basis.

This must be concluded before the first anniversary of Marion Kelly's death. Has the drug been paid for to date? Have all the administration costs been met? Will the Minister ensure the HSE communicates directly with the Alpha-1 group and with the Kelly family on the current status of the negotiations? I am losing confidence that the people dealing with this from the HSE are prioritising it to the level required.

I also hope that this can be concluded quickly. On the question of the administration costs, I have no information other than what I have in front of me. The HSE agreed that because of the unique and exceptional circumstances these 19 patients find themselves in, it would fund the provision of the necessary nursing services to ensure patients could continue to receive the medicine. I will certainly check that that has been met because it was the commitment given. It will be honoured. I will also ask that the HSE arranges to meet with the Alpha-1 group and the family of Marion Kelly to update them directly about where this matter stands. I hope that both the company and the HSE can resolve this quickly. I accept that it has been going on for quite a long time. I extend my sympathies and thoughts to the family of Marion Kelly.